Therapeutic Clinical Trial Eligibility and Enrollment among Women with Breast Cancer: Implications for Understanding Trial Disparities.

Introduction: Therapeutic clinical trials frequently lack diverse representation, hindering generalizability and exacerbating preexisting disparities in clinical outcomes. This study explored associations between breast cancer patient demographics, clinical trial eligibility, and enrollment in a National Cancer Institute (NCI)-designated cancer center.

Patients And Methods: This prospective cohort study included patients with breast cancer screened for therapeutic clinical trials from July 2020 to January 2024.

A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC.

Purpose: Opportunities exist for patients with metastatic breast cancer (MBC) to engage in shared decision-making (SDM). Presenting patient-reported data, including patient treatment preferences, to oncologists before or during a treatment plan decision may improve patient engagement in treatment decisions.

Methods: This randomized controlled trial evaluated the standard-of-care treatment planning process vs.

Why location matters: associations between county-level characteristics and availability of National Cancer Oncology Research Program and National Cancer Institute sites.

Background: The majority of patients with cancer seek care at community oncology sites; however, most clinical trials are available at National Cancer Institute (NCI)-designated sites. Although the NCI National Cancer Oncology Research Program (NCORP) was designed to address this problem, little is known about the county-level characteristics of NCORP site locations.

Methods: This cross-sectional analysis determined the association between availability of NCORP or NCI sites and county-level characteristic theme percentile scores from the Center for Disease Control and Prevention's Social Vulnerability Index themes.

Understanding the financial cost of cancer clinical trial participation.

Background: Though financial hardship is a well-documented adverse effect of standard-of-care cancer treatment, little is known about out-of-pocket costs and their impact on patients participating in cancer clinical trials. This study explored the financial effects of cancer clinical trial participation.

Methods: This cross-sectional analysis used survey data collected in December 2022 and May 2023 from individuals with cancer previously served by Patient Advocate Foundation, a nonprofit organization providing social needs navigation and financial assistance to US adults with a chronic illness.

TBCRC 057: Survey about willingness to participate in cancer clinical trials during the pandemic.

Background: Breast cancer patients experienced heightened anxiety during the pandemic. Also, modifications to clinical trial activities allowing for virtual platforms, local assessments, and greater flexibility were introduced to facilitate participation. We sought to evaluate the association between pandemic-related anxiety and willingness to participate in trials and how pandemic-era modifications to trial activities affect the decision to participate.

Factors associated with completeness in documentation of diagnostic work-up and treatment in patients with breast cancer in Sudan.

Purpose: This study evaluates the relationship between geography and ethnicity on the completeness of documentation of diagnostic work-up and treatment modalities in Sudan for patients with breast cancer.

Methods: This retrospective study used data abstracted from patients with breast cancer receiving cancer care at Sudan's largest cancer centre (Radiation and Isotopes Center Khartoum) in 2017. Patient demographic and clinical characteristics were abstracted from paper medical records.

Cancer-Related Financial Hardship Screening as Part of Practice Transformation.

Background: Data on financial hardship, an "adverse event" in individuals with cancer, are needed to inform policy and supportive care interventions and reduce adverse economic outcomes.

Methods: Lay navigator-led financial hardship screening was piloted among University of Alabama at Birmingham oncology patients initiating treatment in October 2020. Financial hardship screening, including reported financial distress and difficulty, was added to a standard-of-care treatment planning survey.

Evaluating Nurses' Time to Response by Severity and Cancer Stage in a Remote Symptom Monitoring Program for Patients With Breast Cancer.

Purpose: Remote symptom monitoring (RSM) using electronic patient-reported outcomes enables patients with cancer to communicate symptoms between in-person visits. A better understanding of key RSM implementation outcomes is crucial to optimize efficiency and guide implementation efforts. This analysis evaluated the association between the severity of patient-reported symptom alerts and time to response by the health care team.

Associations Between Patient-Perceived Cancer Curability and Advance Directive Completion.

Despite Advance Care Planning recommendations for patients with cancer, many lack Advance Directives (ADs). AD disparities persist among Black, Indigenous, or People of Color (BIPOC) patients. Based on a hypothesized correlation, we examined the association between patient-perceived cancer incurability and AD completion.

Effect of prior treatments on post-CDK 4/6 inhibitor survival in hormone receptor-positive breast cancer.

Purpose: Multiple treatment options exist for patients with metastatic breast cancer (MBC). However, limited information is available on the impact of prior treatment duration and class on survival outcome for novel therapies, such as cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ HER2-) MBC.

Methods: This study used a nationwide, de-identified electronic health record-derived database to identify women with HR+ HER2- MBC who received at least one CDK 4/6i between 2011 and 2020.

Patient-reported discrimination among limited-resourced cancer survivors: a brief report.

Purpose: Healthcare discrimination has been associated with health disparities including lower cancer screenings, higher medical mistrust, and strained patient-provider relationships. Our study sought to understand patient-reported discrimination among cancer survivors with limited resources living in the United States.

Design And Methods: We used cross-sectional survey data distributed by the Patient Advocate Foundation (PAF) in 12/2020 and 07/2021.

Vaccine Hesitancy versus Vaccine Behavior in Patients with Chronic Illness.

While vaccine hesitancy has been described for the general population, vaccine hesitancy among the chronically ill has not been well explored. This study assesses COVID‑19 vaccine hesitancy and uptake among individuals with chronic illness using nationwide survey data. We analyzed vaccine hesitancy prior to and after approval of the vaccines using multinomial logistic regression and binomial logistic regression, respectively.

Adaptation of Remote Symptom Monitoring Using Electronic Patient-Reported Outcomes for Implementation in Real-World Settings.

Purpose: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers.

Methods: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman's Framework for Modifications and Adaptations.

Ineligible, Unaware, or Uninterested? Associations Between Underrepresented Patient Populations and Retention in the Pathway to Cancer Clinical Trial Enrollment.

Purpose: Cancer clinical trials can benefit current and future patients; however, Black patients, rural residents, and patients living in disadvantaged areas are often underrepresented. Using an adapted version of Unger and colleagues' model of the process of clinical trial enrollment, we evaluated the relationship between underrepresented patient populations and trial end points.

Methods: This retrospective study included 512 patients with breast or ovarian cancer who were prescribed a therapeutic drug at the University of Alabama at Birmingham from January 2017 to February 2020.

Associations between geography, decision-making style, and interest in cancer clinical trial participation.

Background: Clinical trials offer novel treatments, which are essential to high quality cancer care. Patients living in rural areas are often underrepresented in clinical trials due to several factors. This study evaluated the association between rurality and interest in clinical trial participation, change in interest, and treatment decision-making style preference.

Health insurance and financial hardship in cancer survivors during the COVID-19 pandemic.

Uninsured or underinsured individuals with cancer are likely to experience financial hardship, including forgoing healthcare or non-healthcare needs such as food, housing, or utilities. This study evaluates the association between health insurance coverage and financial hardship among cancer survivors during the COVID-19 pandemic. This cross-sectional analysis used Patient Advocate Foundation (PAF) survey data from May to July 2020.

Determinants of telemedicine adoption among financially distressed patients with cancer during the COVID-19 pandemic: insights from a nationwide study.

Purpose: Telemedicine use during the COVID-19 pandemic among financially distressed patients with cancer, with respect to the determinants of adoption and patterns of utilization, has yet to be delineated. We sought to systematically characterize telemedicine utilization in financially distressed patients with cancer during the COVID-19 pandemic.

Methods: We conducted a cross-sectional analysis of nationwide survey data assessing telemedicine use in patients with cancer during the COVID-19 pandemic collected by Patient Advocate Foundation (PAF) in December 2020.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

Background: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers.

Building Sustainable Practice Transformation Through Payment Reform Initiatives.

Purpose: Novel value-based payment approaches provide an opportunity to deploy and sustain health care delivery interventions, such as treatment planning documentation. However, limited data are available on implementation costs.

Methods: We described key factors affecting the cost of implementing care improvements under value-based payments, using treatment planning and Medicare's Oncology Care Model as examples.

Examining the association among fear of COVID-19, psychological distress, and delays in cancer care.

Background: Given the high risk of COVID-19 mortality, patients with cancer may be vulnerable to fear of COVID-19, adverse psychological outcomes, and health care delays.

Methods: This longitudinal study surveyed the pandemic's impact on patients with cancer (N= 1529) receiving Patient Advocate Foundation services during early and later pandemic. Generalized estimating equation with repeated measures was conducted to assess the effect of COVID-19 on psychological distress.

Exclusion criteria of breast cancer clinical trial protocols: a descriptive analysis.

Purpose: 3-8% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines.

Methods: This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004 and 2020.

Clinical trial representativeness and treatment intensity in a real-world sample of women with early stage breast cancer.

Purpose: The extent to which evidence-based treatments are applied to populations not well represented in early stage breast cancer (EBC) trials remains unknown. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials.

Methods: This retrospective cohort study used real-world data to evaluate the intensity (high or low) of EBC chemotherapy by patient characteristics (age, race and ethnicity, presence of comorbidity) denoting clinical trial representation status (well represented, underrepresented, unrepresented) for patients diagnosed from 2011 to 2020.

Survival in the Real World: A National Analysis of Patients Treated for Early-Stage Breast Cancer.

Purpose: Many patient population groups are not proportionally represented in clinical trials, including patients of color, at age extremes, or with comorbidities. It is therefore unclear how treatment outcomes may differ for these patients compared with those who are well-represented in trials.

Methods: This retrospective cohort study included women diagnosed with stage I-III breast cancer between 2005 and 2015 in the national CancerLinQ Discovery electronic medical record-based data set.